Quest for Tumour Evolution of Non-small Cell Lung Cancer

Non-small Cell Lung Cancer Clinical Trial

Official title:

Quest for Tumour Evolution of Non-small Cell Lung Cancer in Chinese (Unicorn-Quest)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05811169
• Other study ID #: UW 20-145
• Status: Active, not recruiting
• Start date: February 15, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: February 2023
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To study and comprehend the evolutionary and genomic landscape between primary and metastatic sites and the dynamics of intratumour and intertumour heterogeneity over time with reference to the treatment modalities for each Chinese patient with non-small cell lung cancer.

Description:

The importance of intratumour and intertumour heterogeneity in non-small cell lung cancer has been extensively interrogated recently. However there is a lack of similar data associated with treatment and survival outcomes in Chinese population. Unicorn-Quest, a prospective observational study of Chinese patients with either primary or metastatic non-small cell lung cancer, aims to identify the evolutionary changes from the primary tumour, regional nodes and distant metastases of the same patients and among different patients, through multiregion and longitudinal tumour and nodal collection with next-generation sequencing. By following non-small cell lung cancer from early stage to relapse or distant metastasis, identifying the changes of genomic landscape with correlation with treatment and survival outcomes, this study may help identify unique cancer trajectories and novel therapeutic targets for non-small cell lung cancer in Chinese population.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Written Informed consent

• Patients =18 years of age, with histologically confirmed non-squamous non-small cell lung cancer who plan to receive active anti-cancer treatment for their non-small cell lung cancer.

• Sufficient tissues with a minimum of two tumour or nodal regions are available for the study based on pre-operative imaging and post-operative pathological findings.

Exclusion Criteria:

• Any other* malignancy diagnosed or relapsed at any time, which is currently being treated (including by hormonal therapy).

Any other* current malignancy or malignancy diagnosed or relapsed within the past 3 years**.

*Exceptions are: non-melanomatous skin cancer, stage 0 melanoma in situ, and in situ cervical cancer

**An exception will be made for malignancies diagnosed or relapsed more than 2, but less than 3, years ago only if a pre-operative biopsy of the lung lesion has confirmed a diagnosis of NSCLC.

• Psychological condition that would preclude informed consent

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Genetic:
• Next generation sequencing
Next generation sequencing

Locations

Country	Name	City	State
Hong Kong	Department of Clinical Oncology, Queen Mary Hospital	Hong Kong

Sponsors (8)

Lead Sponsor	Collaborator
The University of Hong Kong	Pamela Youde Nethersole Eastern Hospital, Prince of Wales Hospital, Shatin, Hong Kong, Princess Margaret Hospital, Hong Kong, Queen Elizabeth Hospital, Hong Kong, Queen Mary Hospital, Hong Kong, Tuen Mun Hospital, United Christian Hospital

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intratumour heterogeneity	Number of participants who have single actionable and non-actionable genetic mutations and multiple actionable and non-actionable genetic mutations within the same groups of patients with early and metastatic non-small cell lung cancer	5 years
Primary	Intertumour heterogeneity	Number of participants who have single actionable and non-actionable genetic mutations and multiple actionable and non-actionable genetic mutations of different groups of patients with early and metastatic non-small cell lung cancer	5 years